Neuropsychological, Social, Emotional, and Behavioral Outcomes in Children With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 368
- 主要终点
- Compliance rate for completion of neuropsychological and behavioral battery
研究概览
简要总结
This research trial studies neuropsychological (learning, remembering or thinking) and behavioral outcomes in children and adolescents with cancer by collecting information over time from a series of tests.
详细描述
PRIMARY OBJECTIVES:
I. To institute procedures to ensure a consistent, streamlined, and efficient administration of the neuropsychological/behavioral tests in a cooperative group setting in order to maximize compliance with a standardized assessment battery conducted at 3 standardized time points.
OUTLINE:
Parent and child participants complete the COG Standard Neuropsychological and Behavioral Battery at approximately 9, 30, and 60 months post-diagnosis in a 1-2 hour testing session conducted by a neuropsychologist or psychologist. The Battery consists of measures of intelligence, processing speed, attention, memory, language preference, behavioral/social/emotional function, executive function, adaptive function, and quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must be currently be enrolled or plan to be enrolled on a COG therapeutic study that aims to examine neuropsychological, social, emotional, and/or behavioral functioning
- •The patient must have receptive and expressive language skills in English, French, or Spanish; if a patient meets these criteria but the parent/guardian speaks a language other than English, French, or Spanish, the patient may still be enrolled and tested, and the parent-report measures should be omitted
- •All patients and/or their parents or legal guardians must sign a written informed consent
- •All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
排除标准
- •Patients with a history of moderate to profound intellectual disability (i.e. intelligence quotient [IQ] =< 55) are not eligible for enrollment; PLEASE NOTE: Children with a prior history of attention deficit hyperactivity disorder (ADHD) or a specific learning disability (e.g., dyslexia) are eligible for this study
研究组 & 干预措施
Observational (neuropsychological and behavioral tests)
Parent and child participants complete the COG Standard Neuropsychological and Behavioral Battery at approximately 9, 30, and 60 months post-diagnosis in a 1-2 hour testing session conducted by a neuropsychologist or psychologist. The Battery consists of measures of intelligence, processing speed, attention, memory, language preference, behavioral/social/emotional function, executive function, adaptive function, and quality of life.
干预措施: Cognitive Assessment (Procedure)
Observational (neuropsychological and behavioral tests)
Parent and child participants complete the COG Standard Neuropsychological and Behavioral Battery at approximately 9, 30, and 60 months post-diagnosis in a 1-2 hour testing session conducted by a neuropsychologist or psychologist. The Battery consists of measures of intelligence, processing speed, attention, memory, language preference, behavioral/social/emotional function, executive function, adaptive function, and quality of life.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Compliance rate for completion of neuropsychological and behavioral battery
时间窗: Up to 72 months post-diagnosis
次要结局
未报告次要终点